Kornimate/medical-research-clean huggingface dataset:
a study of ly3484356 in participants with advanced or metastatic breast cancer or endometrial cancer

Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Endometrial Cancer

Summary: the reason for this study is to see if the study drug ly3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.


Eligibility criteria:
inclusion criteria: all study parts: * participants must be willing to provide adequate archival tissue sample * participants must be willing to use highly effective birth control * participants must have adequate organ function * participants must be able to swallow capsules dose escalation- participants must have one of the following: * parts a and b: er+ her2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following: * part a: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (cdk4/6) inhibitor therapy. * part b: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior cdk4/6 inhibitor * cohort e4: no prior everolimus. * cohort e5: no prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (pik3cα) mutation as determined by local testing. * part c: er+, human epidermal growth factor receptor 2 positive (her2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 her2-directed therapies in any setting. * part d: er+, eec that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy. * part e: er+ and her2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease. * part e: participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen. * part e: participants must not have received more than 1 her2-directed regimen or any endocrine therapy for advanced disease or any prior cdk4/6 inhibitor therapy. participants with er+/her2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer exclusion criteria: * participants must not have certain infections such as hepatitis or tuberculosis or hiv that are not well controlled * participants must not have another serious medical condition * participants must not have cancer of the central nervous system that is unstable * participants must not be pregnant or breastfeeding
symptomatic crt patients: real-world experience - barostim™ advancing the level of clinical evidence

Conditions: Heart Failure

Summary: the purpose of this study is to develop valid scientific evidence of the safety and benefit of barostim therapy in the commercial setting in patients that are symptomatic despite having received crt.

this is a non-randomized, prospective, multicenter complementary-study of the rebalance registry. patients who have been implanted with a crt device at least 6-months prior to enrollment are eligible for this complementary-study. up to 150 subjects will be enrolled. data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the study.

Eligibility criteria:
inclusion criteria: * patients can be included if they were implanted with a cardiac resynchronization therapy (crt) device at least six months (180 days) prior to informed consent and are planned for a de novo barostim system implantation. patients must sign an informed consent form before implantation with the barostim system in order to participate in this study. exclusion criteria: * patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the cvrx clinical department.
biotronik - bioflow-iii registry french satellite

Conditions: Coronary Artery Diseases

Summary: for the majority of coronary artery disease (cad) treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedure success. however, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30 to 50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. therefore this observational registry has been designed for the clinical evaluation of the orsiro less requiring coronary revascularization with des. it is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice.


Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject has signed informed consent for data release * subject is geographically stable and willing to participate at all follow up assessments * subject is ≥ 18 years of age exclusion criteria: * subject did not sign informed consent for data release * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media

Keywords: national multicenter observational registry orsiro drug eluting stent stenting treatment of coronary artery disease coronary revascularization pci stemi nstemi ischemia angina acute myocardial infarction small vessels chronic total occlusion
clinical pattern of stroke and transient ischemic attack mimics

Conditions: Stroke; Transient Ischemic Attack

Summary: wide range of diagnoses may present like stroke, called stroke mimics as well as transient ischemic attacks .


Eligibility criteria:
inclusion criteria: * male or female * aged above 18 years * accept all requirements of the study exclusion criteria: .refuse participation in the study
training of eccentric lower extremity function after sci

Conditions: Spinal Cord Injury

Summary: this project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.

lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (sci). even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with sci. this proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.

Eligibility criteria:
individuals with sci: inclusion criteria: * medically approved * discharged from outpatient rehabilitation for 6 months * incomplete sci based on asia impairment score (ais c or d) at neurologic level c1-t10 * ability to take some steps overground and on the treadmill * 18-90 years old. * ability to speak english. note: the quality of life measures have not been validated yet in non-english speaking populations. exclusion criteria: * evidence of lower motor neuron injury in the legs * use of botox in the past 3 months * pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, hiv) * acute deep vein thrombosis * skin wounds in regions where harness or hands provide support * pregnancy. note: persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with sci. * cognitive conditions that preclude providing informed consent * ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment * persistent orthostatic hypotension (drop of bp \>30mmhg in treadmill and harness equipment) * hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study * participation in any other concurrent exercise programs. note: use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.
determining the impact of a new physiotherapist led primary care model for back pain

Conditions: Back Pain

Summary: this is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in canada.

this study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. the primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Eligibility criteria:
inclusion criteria: * adults (18 years and over) with back pain of any duration * seeking primary care for back pain at a participating site * primary care visit may be a first or repeat visit exclusion criteria: * patients who do not consent to participation * patients who report being unable to understand, read, and write english
the effect of visual feedback on function, stability and quality of life in transtibial amputation

Conditions: Amputation; Traumatic Amputation

Summary: this study was conducted to examine the effect of visual feedback on function, stability and quality of life in transtibial amputees. a total of 24 subjects who had unilateral transtibial amputations, used prosthesis with total surface bearing socket (tsb) for at least 1 year and volunteered to participate in the study were included. before and after treatment subjects were evaluated with "lasar posture" for prosthetic weight bearing (pwb), "berg balance scale (bbs)" and "timed up\& go test (tug)" for balance and functional mobility, "2-minute-walk-test (2mwt)" for physical performance, "satisfaction with the prosthesis questionnaire (satpro)" for prosthetic pleasure and "nottingham health profile (nhp)" for health- related quality of life. participants were randomly divided into two equal groups as study and control groups. after the evaluations the same exercises; pwb exercises, balance exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different grounds were applied to the the study group with visual feedback methods and control group.

inclusion criteria: 1. had transtibial amputation 2. \>18 years old 3. had total surface bearing socket at least one year outcome measures: * prosthetic weight bearing * berg balance scale * timed up \&go test * 2 minute walk test * satisfaction of prosthesis questionnare * nottingham health profile

Eligibility criteria:
inclusion criteria: * had unilateral transtibial amputations, * used prosthesis with total surface bearing socket (tsb) for at least 1 year * volunteered to participate in the study exclusion criteria: * had any neurological disorders * had any cognitive problems

Keywords: transtibial amputation visual feedback rehabilitation
ear acupuncture during chemotherapy infusion for breast cancer, a feasibility study

Conditions: Breast Cancer

Summary: this research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.

chemotherapy drugs used to treat cancer can cause many symptoms. some of the most common symptoms of receiving chemotherapy are nausea, vomiting, and anxiety. these symptoms can affect the quality of life of cancer patients. medications can help ease these, but many patients continue to experience symptoms despite these treatments. acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea. ear acupuncture is a type of acupuncture that involves the stimulation of points on the external ear. a few studies have suggested that ear acupuncture may help to reduce symptoms of nausea and anxiety during chemotherapy. this study is being done to evaluate the potential benefits of using ear acupuncture to reduce symptoms like nausea and anxiety for women receiving chemotherapy for breast cancer.

Eligibility criteria:
inclusion criteria: * history of histologically or cytologically proven stage i-iii breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 * signed informed consent exclusion criteria: * receiving weekly chemotherapy * unstable cardiac disease or myocardial infarction within 6 months prior to study entry * uncontrolled seizure disorder * pregnancy or potential pregnancy * active clinically significant uncontrolled infection * prior use of acupuncture within 3 months prior to the study entry * uncontrolled major psychiatric disorders, such as major depression or psychosis * metastatic breast or other cancer

Keywords: acupuncture breast cancer
the effect of ly333531 on protein in the urine in patients with type 2 diabetes

Conditions: Diabetic Nephropathy

Summary: the purpose of this study are to determine 1) whether ly333531 can reduce urinary albumin/creatinine excretion in patients with type ii diabetes and persistent albuminuria 2) whether ly333531 reduces urinary tgf-b, 3) the safety of ly333531 and any side effects that may be associated with it.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * greater than or equal to 30 years of age * albumin to creatinine ratio (greater than 200 mg/g and less than 2000 mg/g) 4)without language barrier. exclusion criteria: * serum creatinine greater than 2.0 mg/dl males or greater than 1.7 mg/dl females * b/p greater than 150 systolic and greater than 90 diastolic * hemoglobin alc greater than 11% * liver function tests 2 times upper limit of normal * poor medical or psychiatric risk.

Keywords: persistent albuminuria
sub-occipital muscle inhibition in tension type headache

Conditions: Tension-Type Headache

Summary: the main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy.

this study is based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy improves symptoms in patients with tension type headache and cervicogenic headache. the purposes of this study are: * evaluate the effectiveness of treatment based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy in patients with tension type headache. * evaluate the effects of treatment caused in upper cervical movement. * evaluate the effects of treatment caused in neck pain. * evaluate the effects of treatment caused in headache.

Eligibility criteria:
inclusion criteria: * patients diagnosed with tension type headache * in prophylactic regimen and with medical control exclusion criteria: * patients with neurological or cognitive impairments that prevent understanding the questionnaires * patients diagnosed with other types of headaches * patients who have not signed the informed consent document

Keywords: tension-type headache physical therapy modalities musculoskeletal manipulations sub-occipital muscle inhibition technique
to investigate the role of upstream high dose statin in stemi

Conditions: Acute Myocardial Infarction

Summary: this is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg atorvastastin-calcium in patients undergoing percutaneous intervention for acute stemi.


Eligibility criteria:
inclusion criteria: 1. any patient of 25 to 90 years of age admitted or transferred to western pennsylvania hospital or allegheny general hospital with a diagnosis of stemi undergoing emergent percutaneous intervention (pci) to the culprit coronary artery. stemi is defined as greater than 1mm st segment elevation on electrocardiogram. 2. elevated cardiac biomarkers (troponin-t \> 0.03ng/ml, ckmb\>5ng/ml, or ck\>170 u/l). exclusion criteria: 1. known history of liver disease defined as cirrhosis, alcoholic liver disease, non alcoholic steatohepatitis, hepatitis or any causes of liver failure. 2. renal failure with creatinine \>3mg/dl 3. known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer. 4. cardiovascular arrest and shock.
study in patients with crohn's disease who are steroid dependent, despite previous unsuccessful attempts to reduce steroids due to worsening of crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the effectiveness of leukine to decrease the need for steroid treatment for crohn's disease.

on 29 may 2009, bayer began transitioning the sponsorship of this trial to genzyme. note: this study was originally posted by sponsor berlex, inc. berlex, inc. was renamed to bayer healthcare, inc.

Eligibility criteria:
inclusion criteria: * you must have active crohn's disease at screening and been diagnosed with crohn's disease within 6 months at screening. * you must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease). * you must be able to give yourself an injection of study drug or have another person help you give the injection. * you must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential. exclusion criteria: * you may not be taking medications not allowed on this study. * you may not have had gi surgery or bowel obstruction in the last 6 months. * you may not have ever taken this drug or drugs of similar type in the past.
a study of hemodynamic cardiopulmonary exercise for chd

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.


Eligibility criteria:
inclusion criteria: * congenital heart disease diagnosis * undergoing clinically indicated cardiac cath exclusion criteria: * unable to consent * pregnancy
the effect of coq10 administration on hemodialysis patients

Conditions: Chronic Renal Failure; Hemodialysis

Summary: the purpose of this study is to examine whether coq10 administration is effective as an antioxidant in hemodialysis patients.

oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. this study investigates whether coq10 administration is effective for protecting oxidative stress in hemodialysis patients. the subjects were recruited from day-time hemodialysis patients in iwata city hospital. 100 mg coq10 was administered every hd for 6 months. several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.

Eligibility criteria:
inclusion criteria: * hemodialysis for at least 6 months exclusion criteria: * none

Keywords: coq10 hemodialysis oxidative marker antioxidant
4 vs 7 points blood glucose monitoring in gestational diabetes on dietary modification

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

all women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. they will be followed up 4 weekly and the pregnancy outcomes will be evaluated.

Eligibility criteria:
inclusion criteria: * aged 18-45 years old * pregnant women with gestational diabetes mellitus on diet modification * confirmed gestational diabetes mellitus using national institute for health and care excellence guideline by 75g oral glucose tolerance test after 14 weeks * gestational age at recruitment 20-34 week exclusion criteria: * bad obstetrics history. * women with underlying medical disorders such as hypertension, autoimmune diseases on steroids * fetal anomaly. * women planning to deliver in other centres * women who refuse to participate

Keywords: diet modification, 4 and 7 points monitoring
the effect of lasik on the calibration of iol formula calculation: a comparative study

Conditions: Cataract Senile

Summary: direct comparison study between previous lasik or non-lasik cataract eyes, the performance between non-lasik and lasik patients were (i) ophthalmic examinations: udva, cdva and uncorrected near visual acuity (unva) (40cm) and (ii) refractive prediction error: defined as difference between postoperative sphere and target refraction.


Eligibility criteria:
inclusion criteria: * presence of cataract in both eyes * corrected distance visual acuity under 20/40 * phacoemulsification cataract surgery was arranged for both eyes exclusion criteria: * complicated cataract * corneal opacities or irregularities * corneal astigmatism \> 1.50 diopter * amblyopia, anisometropia * surgical complications such as posterior capsular bag rupture or vitreous loss, iol tilt or decentration * coexisting ocular pathologies, glaucoma, non-dilating pupil, history of intraocular surgery, or retinopathy * optic nerve or macular diseases * refusal or unable to maintain follow-up.